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WASHINGTON – A panel of U.S. health advisers on Tuesday approved children’s doses of Pfizer’s COVID-19 vaccine, bringing the United States closer to starting vaccinations for children aged 5 to 11.

A Food and Drug Administration advisory group voted unanimously with abstention that the vaccine’s benefits in preventing COVID-19 in this age group outweigh the potential risks – including a related side effect to the heart which has been very rare in adolescents and young adults who get much higher dose.

The FDA is not bound by the panel’s recommendation and is expected to make its own decision within days.

If the FDA allows doses for children, there is yet another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the injections and which young people should receive them.

While children are less at risk of severe COVID-19 than older people, children aged 5 to 11 have historically faced significant illness – with more than 8,300 reported hospitalizations, about a third requiring care intensive and nearly 100 deaths.

The dose for young children is only a third of the Pfizer dose already recommended for everyone 12 years and older. Moderna is also studying its vaccine for young children.

THIS IS A CURRENT UPDATE. AP’s previous story follows below.

WASHINGTON (AP) – Child-sized doses of Pfizer’s COVID-19 vaccine could approach as government advisers on Tuesday began questioning whether there is enough evidence that the injections are safe and effective for children from 5 to 11 years old.

A study of elementary school children found that Pfizer injections were almost 91% effective in preventing symptomatic infections, even though young people only received a third of the dose given to adolescents and adults.

In a preliminary analysis last week, Food and Drug Administration examiners said protection “would clearly outweigh” the risk of a very rare side effect in almost any pandemic scenario. Now, FDA advisers are combing through this data to see if they agree.

If the FDA allows doses for children, there is yet another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the injections and which young people should receive them.

While children are less at risk of severe COVID-19 than older people, children aged 5 to 11 have historically faced significant illness – including more than 8,300 hospitalizations, about a third requiring intensive care and nearly 100 deaths, according to FDA vaccine chief Dr. Peter Marks told the advisory committee.

In addition, “the infections have caused many school closures and disrupted the education and socialization of children,” he said.

“I want to acknowledge that there are strong feelings” among the public for and against childhood immunization, Marks added, noting that the discussion would be about scientific data “not about vaccine mandates, which are left behind. to other entities outside of the FDA. “

Full strength injections made by Pfizer and its partner BioNTech are already recommended for all ages 12 and up, but pediatricians and many parents are calling for protection for young children. The extra-contagious delta variant has caused an alarming rise in pediatric infections – and families are frustrated with school quarantines and have to say no to sleepovers and other childhood rites to keep the virus at bay.

States are preparing to roll out injections for small arms – in special vials with orange caps to distinguish them from the vaccine for adults – as soon as the government agrees. More than 25,000 pediatricians and other primary care providers have signed up to offer immunization so far.

The Pfizer study followed 2,268 children aged 5 to 11 who received two injections three weeks apart of either a placebo or a pediatric dose. Young people vaccinated developed anti-virus antibody levels as strong as adolescents and young adults who received the injections at full strength.

And so far, 16 children who received sham injections have developed symptomatic COVID-19 compared to three young people who were vaccinated, meaning the vaccine was nearly 91% effective. Most of the study data was collected in the United States in August and September, as the delta variant increased.

The children’s dosage has also been shown to be safe, with similar or fewer temporary side effects – such as arm pain, fever, or body aches – that teens experience. At the request of the FDA, Pfizer recently recruited another 2,300 young people into the study, and preliminary safety data showed no red flags.

The study is not large enough to detect extremely rare side effects, such as inflammation of the heart that occasionally occurs after the second dose, mainly in young men and adolescents.

The FDA’s independent expert panel will assess whether Pfizer’s vaccine is likely to prevent more COVID-19-related hospitalizations in young children than could be caused by this rare side effect.

FDA analysis calculated that in most continuing pandemic scenarios, the vaccine would prevent around 200 to 250 COVID-19 hospitalizations per 1 million young people vaccinated, with around 58 hospitalizations for heart inflammation. The risk of side effects is based on levels in adolescents, and Pfizer expects it to be much lower in young people receiving the child-sized dose.

Moderna is also studying its vaccine in young children.

The Associated Press’s Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.

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